During a routine annual reserve inspection, visible particles were observed in the above lot number of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. In the interest of patient safety, Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles; therefore, no other lots of product are affected by this recall. Consignees are asked to examine your stocks immediately to determine if you have any of Lot 120016 on hand. If so, discontinue distributing the lot and promptly return all vials to Biotest’s Boca Raton, Florida facility using the enclosed return label.

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